Oxytocin for Weight Loss in Adolescents

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04551482
Phase
PHASE2
Status
Recruiting
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Conditions

  • Obesity, Adolescent
  • Oxytocin

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxytocin nasal spray — DRUG
    24 IU nasal spray, 4 times per day for 12 weeks
  • Placebo — DRUG
    24 IU nasal spray, 4 times per day for 12 weeks

Study Details

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.

Key Dates

Start date
Jul 28, 2021
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oxytocin
    Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
  • Placebo Comparator: Placebo
    Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)

Primary Outcome Measure

Weight [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Elizabeth A Lawson, MD
[email protected]

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By research site
Massachusetts General Hospital· Boston, MA

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